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Methylselenocysteine Effects on Circadian Rhythm

Primary Purpose

Breast Cancer, Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methylselenocysteine
Placebo
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Permanent night shift schedule

Exclusion Criteria:

  • Nutritional supplements that contain selenium
  • Pregnant
  • Breast feeding
  • Heart conditions
  • Chronic lung disease
  • Cancer therapy (current or past)

Sites / Locations

  • Environmental and Occupational Health Sciences Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Methylselenocysteine

Arm Description

Placebo given daily

Methylselenocysteine given daily

Outcomes

Primary Outcome Measures

Determine if selenium (i.e., methylselenocysteine) supplementation can restore disruption of circadian rhythm and estrogen receptor-B levels in shift workers

Secondary Outcome Measures

Full Information

First Posted
May 18, 2012
Last Updated
September 11, 2017
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT01611038
Brief Title
Methylselenocysteine Effects on Circadian Rhythm
Official Title
Chemoprevention of Breast and Prostate Cancers in Shift Workers by Dietary Methylselenocysteine: Effects on Circadian Rhythm and Estrogen Receptor-B Cycling
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to determine if vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore disruption of circadian rhythm in shift workers.
Detailed Description
All living cells have a circadian (daily) rhythm which controls a variety of bodily functions that change throughout the day, including body temperature, sleep, hunger, activity, hormone levels, etc. The circadian rhythm of the body is controlled by the amount of light that enters our eyes, so on our planet the length of the rhythm is 24 hours long. It is therefore reasonable to suspect that upsetting the timing of the rhythm would lead to changes in body function (as commonly experienced in "jet lag") and that prolonged changes might even lead to alterations in bodily functions and contribute to disease. This suggests that people whose service to the community that requires that they often work at night (nurses, doctors, police, hospital staff, firefighters, airline crews, factory workers, etc), might be at elevated risk of developing diseases. Studies have shown that women who do shift work have an elevated risk of breast cancer, probably as a result of altered hormone levels and cycling. Other studies have shown that vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore this disrupted rhythm and possibly decrease this disease risk. Thus, the purpose of this study is to investigate whether taking daily selenium (i.e., methylselenocysteine) will restore the disrupted circadian rhythm in shift workers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Prostate Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo given daily
Arm Title
Methylselenocysteine
Arm Type
Experimental
Arm Description
Methylselenocysteine given daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Methylselenocysteine
Intervention Description
Methylselenocysteine capsule given daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule given daily
Primary Outcome Measure Information:
Title
Determine if selenium (i.e., methylselenocysteine) supplementation can restore disruption of circadian rhythm and estrogen receptor-B levels in shift workers
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Permanent night shift schedule Exclusion Criteria: Nutritional supplements that contain selenium Pregnant Breast feeding Heart conditions Chronic lung disease Cancer therapy (current or past)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard M. Kipen, MD, MPH
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helmut Zarbl, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Study Chair
Facility Information:
Facility Name
Environmental and Occupational Health Sciences Institute
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States

12. IPD Sharing Statement

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Methylselenocysteine Effects on Circadian Rhythm

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